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CTRI Number  CTRI/2021/12/038798 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On: 09/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARATIVE STUDY OF HAEMORRHOIDAL SUPPOSITORY FROM MODERN AND AYURVEDIC VIEW 
Scientific Title of Study   Randomized control clinical study to evaluate the efficacy of Arshoghnivarti and Corect Suppository in Hemorrhoids. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Tanaji Nikam 
Designation  Assistant Professor 
Affiliation  PDEAs College of Ayurveda and research centre  
Address  Dr M.N. Agashe charitable hospital ( Aryangla Hospital), 6 SHUKRUVAR PETH, Department of shalya,first floor, opd no 2.
SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA. department of shalya,Ground floor, opd 123
Pune
MAHARASHTRA
415002
India 
Phone  09850487568  
Fax  -  
Email  drsandeepnikam.ms@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  madhavi sanjay banarase 
Designation  Professor 
Affiliation  PDEAs College of Ayurveda and research centre  
Address  SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA. department of shalya, ground floor ,opd 123.
SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA. department of shalya, ground floor ,opd 123.
Pune
MAHARASHTRA
411044
India 
Phone  9423207569  
Fax  -  
Email  dr.madhavibanarase209@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sandeep Tanaji Nikam 
Designation  Assistant Professor 
Affiliation  PDEAs College of Ayurveda and research centre  
Address  Dr M.N. Agashe charitable hospital ( Aryangla Hospital), 6 SHUKRUVAR PETH. department of shalya,first floor, opd 2
SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA. department of shalya,ground floor ,opd 123.
Pune
MAHARASHTRA
415002
India 
Phone  09850487568  
Fax  -  
Email  drsandeepnikam.ms@gmail.com  
 
Source of Monetary or Material Support  
ARYANGLA HOSPITAL, 6 SHUKRUVAR PETH, SATARA 415001 
PDEAS COLLEGE OF AYTURVD AND RESEARCH CENTRE, AKURDI , PUNE 411044 
 
Primary Sponsor  
Name  SANDEEP TANAJI NIKAM 
Address  PDEAS CARC COLLEGE OF AYURVED AND RESEARCH CENTRE, PUNE-411044 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SANDEEP NIKAM  ARYANGLA HOSPITAL  Dr M.N. Agashe charitable hospital ( Aryangla Hospital), 6 SHUKRUVAR PETH,satara.department of shalya,first floor. opd 2
Satara
MAHARASHTRA 
9850487568

drsandeepnikam.ms@gmail.com 
DR MADHAVI BANARASE  PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI  PRADHIKARAN NIGDI NEAR VITTLE RUKMAYI TEMPLE, AKURDI PUNE 411044.department of shalya,ground floor. opd 123
Pune
MAHARASHTRA 
9423207569

dr.madhavibanarase209@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
PZETs college of Ayurved and research centre,akurdi pune  Approved 
SCM AVM SATARA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ARSHOGHNIVARTI  ONE SUPPOSITARY PER RECTAL TWICE A DAY GHUTA LUBRICATION FOR 15 DAYS 
Comparator Agent  CORECT SUPPOSITARY  ONE SUPPOSITARY PER RECTAL TWICE A DAY FOR 15 DAYS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  PATIENTS DIAGNOSED WITH FIRST, SECOND AND THIRD DEGREE OF HEMORRHOIDES. 
 
ExclusionCriteria 
Details  PATIENTS WITH 4TH DEGREE OF HEMORRHOIDES.
KNOWN CASE OF D.M,HTN,LIVER DISEASES OR MALIGNANCY.
PATIENTS DIAGNOSED WITH FISSURTE IN ANO.
PATIENT WITH CA RECTUM.
PREGNANT AND LACTATING WOMAN.
PATIENT WITH HEMOGLOBIN BELOW 8 GM. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Arshoghnivarti against Corect suppository in Hemorrhoids.  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study adverse effects of Arshoghnivarti and of Corect suppository if any.  15 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  drsandeepnikam.ms@gmail.com

  6. For how long will this data be available start date provided 31-12-2023 and end date provided 01-01-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

TITLE- A RANDOMIZED CONTROL CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARSHOGHNIVARTI AND CORECT SUPPOSITORY IN HEMORRHOIDS.

Research  Question :-

 

Is Arshoghnivarti more effective than Corect suppository in hemorrhoids.

 

Hypothesis –

 

Arshoghnivarti is more effective than Corect suppository in hemorrhoids.

 

NullHypothesis

(Ho) :-Arshoghanivarti is as effective as Corect suppository in hemorrhoids.

 

Alternate Hypothesis

(H1) :-Arshoghnivarti is more effective than Corect suppository in hemorrhoids.

 

(H2) : - Arshoghnivarti is less effective than Corect suppository in hemorrhoids.

Rationale:-

1) Nowadays fast foods, sedentary lifestyles, irregularity in meals etc. have lead to impairment of gastrointestinal system. This has lead to an increase in diseases of the gastrointestinal tract. One of the major groups of these diseases are the ano-rectal diseases.

2)According to Indian journal of surgery the incidence of hemorrhoids is 72% and prevalence rate 38.93% As far as the treatment of hemorrhoids is concerned use of laxatives and surgical therapy is by far the choice of treatment in modern medicine. Surgery is costly and post operative morbidity is frequently seen.

3)Ayurveda offers enteral as well as local therapies for Arsha. In addition to this various surgical and para surgical procedures are also mentioned. A lot of work has been done on arsha. But local drug therapy, its action on local anal mucosa needs exploration. One such refrence is mentioned in BhaishajyaRatnawali.

 

 

 

This reference of Arshoghnivartiseems like an effective local treatment option in hemorrhoids. Ghoshatak or koshataki is ruksha, katu, pachan as well as virechak. This gunas of koshataki may help in the sampraptibhanga of arsha disease2. Also it is mentioned as a drug which can be used in Arsha in the Nighantus.

 Keeping this in mind this study is planned.

Drug review –

A) Trial drug=-

Arshoghnivarti (Suppository) Contents -1

Ghoshatak (Luffaactuangula var.)

Guda (Jaggery) – as a binding agent.

Drugs will be procured from authentic sources. Authentication and standardization will be done.

Final product will be standardized.

B) Control Drug-

Corect suppository-merd  meridian labs

Contents-

Allantoin-0.5% w/w

Hydrocortisone – 0.25% w/w

Lidocain -3% w/w

Zinc oxide-5% w/w

AIM AND OBJECTIVES:-

 

Aim:-

To evaluate and compare the efficacy of Arshoghnivarti and Corect suppository on hemorrhoids.

 

Objectives:-

Primary objective -

To evaluate the efficacy of Arshoghnivarti against Corect suppository in Hemorrhoids.

 

Secondary objective -

To study adverse effects of Arshoghnivarti and of Corect suppository if any.

Materials and Methodology –

Materials -

1. Patients :

Selection Of patients –

Patients diagnosed with hemorrhoids fulfilling the inclusion criteria’s will be selected from subjects coming in the Out patient Department (OPD) and patients admitted in the in patient department (IPD) of the Ayurvedic hospital.

This study is aimed at completing 100 patients.

2. Drug – Drug will be standardized.

Methods of Standardization:

A) Raw material - As per Pharmacopeial(API) guidelines:

B)  IPQC (In process quality control) – As per GMP:

C)Finished product standardization – As per Pharmacopeia Guidelines.

Diagnostic criteria of patients :-

1)Signs and symptoms of hemorrhoids.

2)Per Rectal examination

3) Proctoscopy

GROUPING OF PATIENTS-

 

GROUP A

GROUP B

Drug

Arshoghnivarti(suppository) along with concomitant oral treatment and dietetic advice.

Corect suppository

along with concomitant oral treatment and dietetic advice.

Dosage

1 suppository per rectally twice a day.

suppository will be inserted by lubricating with Ghruta.

 

1 suppository per rectally twice a day.

Route of administration

Per rectal

Per rectal

Duration

15 days

15 days

Study design -

Prospective  randomized control clinicalstudy

 

Screening of patients for diagnosis and inclusion

 

Initial assessment

 

Randomization (lottery method)andGroupallocation

 

 


1.Group A :(50Patients)-

Arshoghnivarti (suppository) per rectally twice a day for 15 days.

 

2. Group B:(50Patients)-

Corect suppository per rectally twice a day for 15 days.

 


Follow up on day 7 of treatment and on completion of treatment 15th day will be taken.

Observations

 

Statisticalanalysis

Conclusion

Duration of study–  15 days

 

Sample size – According to statistics n = 100.

n =Z2pq/e2

z- constant= 1.96

p= prevanlace9= 38.93%-

q=1-p

e= standard error= 10-15%

Considering a drop out of 30% minimum 130 patients will be enrolled in the study. This study is aimed at completing 100 patients.

Data collection methods – A case record form is prepared for detailed data collection. Data will be collected according to the case proforma.

Consent – Informed written Consent will be obtained prior to the trial from each patient.

CRI TERIA  FOR ASSESSMENT

 

SubjectiveParameters:-

1)      Bleeding per rectum

2)      Pruritisani

3)      Pain

4)      Tone of anal sphincter.

 

ObjectiveParameter8:-

Degree of Hemorrhoids

 

SUBJECTIVEPARAMETER GRADATION:-

1.      P/R bleeding Grade –

1st grade – 0- 5 drops.

2nd grade – 6 – 15 drops.

3rd grade – more than 15 drops.

 

2.      Pain –

will be assessed using VAS scale with 0 - 10 score.

 

3.      PruritisAni –

will be assessed using VAS scale with 0 - 10 score

 

    4.   Tone of anal sphincter-

DRESS (  Digital Rectal Examination scoring System)10-  0-5

0- No discernable pressure

3- normal tone

5- Extremely tight sphincter


OBJECTIVEPARAMETERGRADATION –

Degree of Hemorrhoids –

1st degree Hemorrhoids-  Hemorrhoids projecting slightly in the lumen of anal canal, no prolapse.

2nd degree Hemorrhoids– Hemorrhoids prolapse out of he anus while defecation but return spontaneously to the anal canal when defecation ceases.

3rd degreeHemorrhoids– Hemorrhoids prolapse out of he anus while defecation but return manually to the anal.

STATISTICAL ANALYSIS

All observed data collected after the final assessment will be subjected to suitable statistical analysis. The Quantitative data will be analyzed by Statistical Z test and t test paired for within the groups and unpaired for between the groups for overall benefits. Qualitative data will be analyzed with Wilkosons test.

 

 

DISCUSSION:

 

The observed results in both the groups will be compared and the differences and effects will be discussed. Adverse effects if any observed will be discussed.

 

CONCLUSION:-

 

Conclusion will be drawn based on overall assessment, tabulation, statistics and graphic presentation of the data.

 

 

 

SUMMARY-

The comparative clinical study will be summarized in brief after completion of the study.


 
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